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Clinical Laboratory Reporting: Is Your Organization Ready for the New 2016 Reporting?

Understand how your organization must comply with the new clinical laboratory reporting to avoid large daily fees.

How will the new payment rate reporting requirements impact your business? Effective January 1, 2017, Medicare will pay for most clinical laboratory tests using the weighted median of payments labs receive from other payers. Beginning January 1, 2016, each applicable laboratory must report the payment amount and volume of each test paid by each private payer, Medicare Advantage plan, and Medicaid managed care plan. Failure to comply with the reporting requirements may result in a civil money penalty of up to $10,000 per day. This topic will help personnel in clinical laboratories understand the rules for determining whether their lab is an applicable laboratory and thus required to report data on payments for their tests. It will help clinical laboratory personnel understand what data elements need to be collected and reported, and on what timeframes. Medicare's process for assigning payment rates to new tests - clinical diagnostic laboratory tests (CDLTs) and a subset of CDLTs called advanced diagnostic laboratory tests (ADLTs) - is also changing. This information will help you understand how CDLTs and ADLTs differ with respect to assignment of billing codes and payment rates and the key questions to consider in launching a new test on or after January 1, 2017.

Runtime: 90 minutes
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Why Lorman?

Over 33 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Agenda

Background on Section 216 of PAMA

  • Legislative History
  • Major Provisions of CMS' Proposed Rule
  • Timelines for Reporting and New Payment Rates
  • Definition of an Applicable Laboratory

Data Reporting Requirements

  • Compliance Issues
  • Operational Considerations for Labs to Report Data
  • Questions CMS Hasn't Answered About Reporting

Advanced Diagnostic Laboratory Tests (ADLTs)

  • FDA Pathway for ADLTs and Non-FDA Pathway for ADLTs
  • Payment for New Tests
  • Coding and Coverage
  • Recommendations of the Advisory Panel for Clinical Diagnostic Laboratory Tests
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Why Lorman?

Over 33 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Credits

OnDemand Course

This course was last revised on January 28, 2016.

Call 1-866-352-9540 for further credit information.

This program does NOT qualify, nor meet the National Standard for NASBA accreditation.

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Why Lorman?

Over 33 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Faculty

Jennifer B. Madsen, MPH

Jennifer B. Madsen, MPH

Arnold & Porter LLP

  • Health policy advisor in the Washington, DC office of Arnold & Porter LLP
  • Member of the FDA/Healthcare and Legislative/Public Policy practices at Arnold & Porter
  • Practice includes all aspects of regulatory approval and reimbursement for in vitro diagnostics, clinical laboratories, digital health, medical devices, pharmaceuticals and biologics
  • Conducts regular seminars and workshops on topics such as Medicare payment for new technologies and the health policy landscape for personalized medicine
  • Wrote several publications on Medicare payment for molecular diagnostics and FDA regulation of next-generation sequencing
  • Member of the Association for Molecular Pathology, the International Society for Pharmacoeconomics and Outcomes Research, the American Association of Medical Society Executives, and Women in Government Relations
  • B.A. degree in biochemistry, Rice University; M.P.H. degree, Health Policy, Yale School of Public Health
  • Can be contacted at [email protected] or on Twitter® @JenMadsen_DC
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Why Lorman?

Over 33 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

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Product ID: 397399
Published 2016
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